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2019-nCoV Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)

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Product Name

2019-nCoV Antibody Detection Kit (Colloidal Gold Immunochromatographic assay)

Packing Size

25 test/kit

Introduction

Coronaviruses are enveloped non-segmented positive-sense RNA viruses belonging to the family Coronaviridae

and the order Nidovirales and broadly distributed in humans and other mammals. Although most human

coronavirus infections are mild, the epidemics of the two betacoronaviruses, severe acute respiratory syndrome

coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), have caused more

than 10 000 cumulative cases in the past two decades, with mortality rates of 10% for SARS-CoV and 37% for

MERS-CoV. The coronaviruses already identified might only be the tip of the iceberg, with potentially more novel

and severe zoonotic events to be revealed.

In December, 2019, a series of pneumonia cases of unknown cause emerged in Wuhan, Hubei, China, with clinical

presentations greatly resembling viral pneumonia. Deep sequencing analysis from lower respiratory tract samples

indicated a novel coronavirus, which was named 2019 novel coronavirus (2019-nCoV). Thus far, more than 800

confirmed cases, including in health-care workers, have been identified in Wuhan, and several exported cases

have been confirmed in other provinces in China, and in Thailand, Japan, South Korea, and the USA.

2019-nCoV caused clusters of fatal pneumonia with clinical presentation greatly resembling SARS-CoV. Patients

infected with 2019-nCoV might develop acute respiratory distress syndrome, have a high likelihood of admission to

intensive care, and might die. The cytokine storm could be associated with disease severity.

Application

This detection kit is to be used for the in vitro qualitative determination of antibodies specific to 2019-nCoV in

serum, plasma and whole blood.

Principle Of The Procedure

This assay is a double antigen chromatographic lateral flow immunoassay. The test strip in the device includes: 1)

  1. rose pink-colored conjugate pad containing colloidal gold coupled with 2019-nCoV N antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with 2019-nCoV N antigens, and the C line is coated with goat anti mouse antibody. When antibodies specific

to 2019-nCoV are present in the specimen, the T line will become a rose pink-colored band. If antibodies to 2019-nCoV are not present or are present below the detectable level, no T line will develop. The C line should always appear as a rose pink-colored band regardless of the presence of antibodies to 2019-nCoV. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred.

Storage condition and Expiry date

Store all reagents at 2-30, Test strip enclosed in aluminum foil bag, be valid for 20min after unpacked.

The expiry date of the kit is reported on the external label. The expiry date of component is reported on the respective label.

Additional Materials Required

  1. Timer

  1. Disposable test tube

  1. Blood sampling needle (only for peripheral blood)

  1. Centrifuge (only for serum or plasma)

Specimen Collection And Preparation

>span class="s4">. Whole blood should be detected within 12 hours, 2-8 preservation, not frozen; serum and plasma can be preserved at 2-8 supposing that the assay can be carried on within 72 hours, for long-term storage should be frozen at -20°C or lower. Specimens should not be repeatedly frozen and thawed prior to testing. Avoid grossly hemolytic (bright red), lipemic (milky), or icteric samples (after centrifugation).

Assay Procedure

  1. Preparation: Before using this product must reading instruction and kit components and samples should be allowed to reach room temperature (18-25°C) before use, suggesting more than 30 minutes. Write the number of the sample to be tested in the ID area of the test card.

  1. Sample dilution:

Serum/plasma: Pipette 20μl of serum/plasma and 1 drop (35μl) of sample dilution in the sample well (S), after 1-2s, pipette another drop (35μl) of sample dilution in the sample well (S);

Whole blood: Pipette 40μl of whole blood and 1 drop (35μl) of sample dilution in the sample well (S), after 1-2s, pipette another drop (35μl) of sample dilution in the sample well (S);

  1. Reaction: After loading, the test card should be put at room temperature and read the result after 3 minutes. The result is not valid after 20 minutes.

Test Limitations

  1. This test is a qualitative assay for in vitro diagnostic use only. A positive result does not distinguish active infection from colonization of 2019-nCoV. Therefore, positive results should always be evaluated with other confirmatory methods available to the physician.

   2. The detection kit is for in vitro diagnostic use and the detection of antibodies in serum, plasma and whole blood, the result is just a qualitative analysis, not a quantitative detection.

   3. Read the result in 3 to 20 minutes. The result is not valid after 20 minutes.

Performance Evaluation

  1. Compared with the gold standard (PCR and gene sequencing), high positive/negative coincidence rate. Sensitivity: 89.78%, specificity: 99.26>#/span###

  1. 2019 n-CoV test card can detect the titer is 1:8 antibody.

Warnings And Precautions

  1. For in vitro diagnostic use only.

  1. Do not use the kit components beyond the labeled expiration date.

  1. For single time use only.

  1. Do not use components from different batches;

  1. Do not use kit that are delivered damaged or that show evidence of leakage from reagent vials.

  1. Remove the test card should be in 20 minutes after use as soon as possible.

  1. Do not touch the membrane;

  1. The waste should be disposed after disinfected.

References

  1. Chaolin Huang, Yeming Wang, Xingwang Li, Lili Ren, Jianping Zhao, Yi Hu et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395: 497–506.

  1. Chandler J, et al. The Place of gold in rapid tests [J]. Journal of IVD Technology, 2000, 6:37-49.

  1. Yang Zhenxiu. Colloidal gold labeling immunoassay application [J]. Mark immune analysis and clinical, 1997, 4

  1. : 91-93.